Chemical - Quality, Chemical - Research and Development, Chemical Engineering
CONTINUUS is looking to hire a full-time QA Manager, who will perform the following tasks:
Lead the development and implementation of a comprehensive Quality Management System
Develop/write the required documentation (e.g., SOPs), based on discussions with the technical team
Create qualification and validation processes for novel continuous unit operations, based on discussions with the technical team
Prepare documents for and participate in meetings with regulatory agencies
Manage and execute all quality initiatives at CONTINUUS
Bachelor's degree in a scientific field, including chemistry or pharmacy; advanced degree preferred
Knowledge of pharmaceutical quality systems supporting development and manufacturing environments
Experience with small companies and establishing a culture of quality
Sound knowledge of international pharmaceutical regulations, especially Good Manufacturing Practices requirements of major Health Authorities (e.g., US FDA, European Health Authorities)
Minimum 2-5 years of working in a Good Manufacturing Practices environment, ideally in more than one of the following areas: development, analytical laboratory operations, chemical and process development, active pharmaceutical ingredient development or manufacturing operations
Minimum 2-5 years of working in Quality Assurance (QA) in one or more of the above areas; experience in developing and/or implementing Quality Management Systems preferred
Working experience with innovative technologies and their development and QA requirements (e.g., Quality by Design, Process Analytical Technologies, continuous manufacturing or related technologies)
Capable of working independently and as part of a cross-functional team of experts; capable of influencing and creating alignment across multiple functional areas
Strong leadership presence with ability to effectively interact with and present to senior management, clients, and health authority representatives (e.g., inspectors)
High agility in adapting to changing environments and regulatory requirements (e.g., ability to apply existing quality principles/concepts to novel technologies and modes of production)
Strong communication and negotiation skills, good listener
Mindset of continuous improvement; able to challenge the status quo to achieve the best outcome for the organization
Additional Salary Information: We offer medical, vision, and dental insurance, and a 401k plan.
About CONTINUUS PHARMACEUTICALS
CONTINUUS’ mission is to produce high-quality drugs that can be delivered to patients more effectively and at a lower cost. In achieving this goal, we look to radically transform the pharmaceutical manufacturing industry, steering it away from outdated batch systems to state-of-the-art continuous processes.
CONTINUUS is leveraging a novel continuous manufacturing platform called Integrated Continuous Manufacturing (ICM), initially developed through an $85 M joint research project between Novartis and MIT. With ICM, we will improve affordability and accessibility of pharmaceuticals on a global scale.
Our work is critical because the current manufacturing systems are time- and cost-inefficient, and are beset with quality problems. It is not unusual for manufacturing lead times, from start to finish, to be over one year, and studies have shown that the industry loses over $50 B annually due to wasteful processes. More importantly, these problems impact patient care. Hundreds of drugs are placed on the US FDA drug shortage website, many of which are life-saving (e.g., oncology drugs). To solve these problems, we offer a number of solutions.
In addition, CONTINUUS is current...ly collaborating with hospital systems and pharmacy chains to establish its own generic business, where high-quality, low-cost drugs will be manufactured in the United States.
To achieve our goals, CONTINUUS has assembled a team of talented engineers and scientists, with skills ranging from analytical chemistry to drug formulation. We have also established strategic partnerships with I.M.A. Industria Macchine Automatiche, a global leader in pharmaceutical equipment, and New England Controls, the local business partner of Emerson Process Management.